The Effect of Paliperidone Palmitate in Schizophrenia

Schizophrenia Clinical Trial

— sustenna  

Official title:

The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860781
• Other study ID #: R092670-SCH-4008
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2013
• Last updated: December 6, 2015
• Start date: August 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.

Description:

In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 18 ~ 65

• Patient with schizophrenia according to DSM-IV criteria

• Patient have signed on the informed consent, and well understood the objective and procedure of this study.

• PANSSS total score <120

• each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16

• three different groups ( other antipsychotics refractory schizophrenia patitents :

CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3)

• Competent patient who is manage to answer the questionnaires.

• In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

• No history of antipsychotics prescription

• History of NMS(Neuroleptic malignant syndrome)

• Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER

• clozapine medication within 1 month before screening

• SSRI, MAOI, TCA medication within 2 months

• Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months

• patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion

• current or previous history of drug depedence according to DSM-IV

• Pregnant or breast-feeding female patient

• Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion

• history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)

• History of participating to other investigational drug trial within 1month prior to screening

• Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• paliperidone palmitate
paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGI-S,I: Clinical Global Impression-Severity, Improvement		24 weeks	No
Secondary	PANSS: Positive and Negative Syndrome Scale		24 weeks	No
Secondary	CRS: Clinician Rating Scale		24 weeks	No
Secondary	KDAI-10: Korean Drug Attitude Inventory-10		24 weeks	No
Secondary	SWN: Subjective Well-being Under Neuroleptic Treatment		24 weeks	No
Secondary	DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae		24 weeks	No
Secondary	injection site pain -VAS: Visual Analog Scale		24 weeks	No
Secondary	LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale		24 weeks	Yes